The following data is part of a premarket notification filed by Advanced Surgical Intervention, Inc. with the FDA for Uroplasty Tcu Prostatic Urethroplasty Catheter.
| Device ID | K902585 |
| 510k Number | K902585 |
| Device Name: | UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER |
| Classification | Dilator, Urethral |
| Applicant | ADVANCED SURGICAL INTERVENTION, INC. 951 CALLE AMANECER San Clemente, CA 92672 |
| Contact | Barry M Calvarese |
| Correspondent | Barry M Calvarese ADVANCED SURGICAL INTERVENTION, INC. 951 CALLE AMANECER San Clemente, CA 92672 |
| Product Code | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-12 |
| Decision Date | 1990-08-27 |